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Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219414
First Posted: September 22, 2005
Last Update Posted: September 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Frankfurt Research Institute GmbH
  Purpose
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Condition Intervention Phase
Ulcerative Colitis Device: Adacolumn Apheresis System Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Otsuka Frankfurt Research Institute GmbH:

Primary Outcome Measures:
  • Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.

Estimated Enrollment: 42
Study Start Date: June 2005
Estimated Study Completion Date: June 2006
Detailed Description:
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219414


Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Investigators
Principal Investigator: Robert Lofberg, Prof. IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Principal Investigator: Toshifumi Hibi, Prof. Keio University, Tokyo, Japan
  More Information

ClinicalTrials.gov Identifier: NCT00219414     History of Changes
Other Study ID Numbers: 512-04-205-CS
First Submitted: September 19, 2005
First Posted: September 22, 2005
Last Update Posted: September 27, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases